HEMODIALYSIS CONCENTRATE SOLUTION— 510(k) K792513

Substantially Equivalent

Mid Atlantic Nephrology Center

FDA 510(k) clearance K792513 for HEMODIALYSIS CONCENTRATE SOLUTION, Substantially Equivalent on 1980-04-08. Applicant: Mid Atlantic Nephrology Center.

Clearance details

Applicant: Mid Atlantic Nephrology Center
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 1979-12-05
Decision date: 1980-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.